GO FOR IT Trial Oral Abstract Presentation

Does an Intensive Two-Week Post
Residency-Match M4 Elective
Improve Competency Prior to
Starting OBGYN Residency?
Gynecology and Obstetrics Fundamentals of Residency: Internship Training Trial

Francis S. Nuthalapaty, MD
For

Collaborative
Support for this project was made possible in part by the

APGO Medical Education Endowment Fund
and the

Office of Philanthropy and Partnership

Investigators
Greenville Health System/University of South
Carolina School of Medicine

Carolinas Medical Center

• 

Francis S. Nuthalapaty, MD (PI)

• 

H. Lee Higdon, PhD

• 

David A. Forstein, DO

• 

Robert V. Higgins, MD

Medical College of Georgia
• 

Palmetto Health/University of South Carolina
School of Medicine

• 

Chadburn Ray, MD

• 

Medical University of South Carolina
Ashlyn Savage, MD

Sarah Smith, MD

University of Tennessee at Knoxville

Florida State University College of Medicine

• 

• 

Julie Z. DeCesare, MD

St. Vincent’s Hospital
•  Spencer G. Kuper, MD

University of Tennessee Memphis

• 

Claudette Shepherd, MD

Nikki B. Zite, MD

Mayo Clinic College of Medicine
• 

Brian C. Brost, MD

APGO Medical Education Endowment Fund and the Greenville Hospital System Office of Philanthropy and Partnership

Disclosure

I have no relevant conflicts of
interest to disclose


Purpose of the M4 Year
Walling and Merando, Acad Med 2010

1. To facilitate completion of the
predoctoral phase of medical education
2. To transition to the residency phase of
medical education


Study Objective
To determine the impact of
participation in an intensive twoweek post residency-match M4
elective, as compared to usual
student activities, on basic clinical,
procedural, and knowledge
competencies assessed at the start
of OBGYN internship.


Study Design
Phase 1
Oct 2011 – Sept 2012

Collaborator
recruitment,
training and
IRB approval


Collaborative Centers
8 ACGME Accredited Residency Programs:

1. Greenville Health System/University of South Carolina Program | Greenville, SC
2. Carolinas Medical Center Program | Charlotte, NC
3. Florida State University College of Medicine Program | Pensacola, FL
4. Medical College of Georgia Program | Augusta, GA
5. Medical University of South Carolina Program | Charleston, SC
6. Palmetto Health/University of South Carolina School of Medicine | Columbia, SC
7. University of Tennessee Program | Memphis, TN
8. University of Tennessee Medical Center at Knoxville Program | Knoxville, TN


Study Design
Phase 1
Mar 2012 – Sept 2012

Collaborator
recruitment,
training and
IRB approval

Phase 2
Oct 2012 – Jan 2013

Participant
recruitment
during
residency
interviews

Phase 3

Phase 4

March 2013

April 2013 – June 2013

Participant
enrollment

Group
assignment,
study
interventions
and posttesting


Study Design
Contingency Plan
Intervention
Study
Population

Measurement

Randomize
Control

Measurement

Study
Group 1

Intervention

Measurement

Study
Group 2

Control

Measurement

Experimental
post-test only
control group

Quasi
experimental
static group

APGO Medical Education Endowment Fund and the Greenville Health System Office of Philanthropy and Partnership

Study Subjects
•  Inclusions:
–  Participated in the 2013 NRMP
–  Applied to ObGyn Residency
–  Matched into one of the Collaborative Centers
–  Available to relocate to Primary Study Center
from April 15th – 26th, 2013

Study Subjects
•  Exclusions:
–  Unavailable to complete end-of-study
assessments


APGO Medical Education Endowment Fund and the Greenville Hospital System OfAice of Philanthropy and Partnership

Curriculum Design
•  APGO/CREOG Milestone 1 Project Learning
Outcomes
–  35 Medical Knowledge
–  29 Clinical / Procedural Skills

•  Ranked in order of importance
–  19 Medical Knowledge
–  14 Clinical / Procedural Skills


Clinical/Procedural Skills
1. 
2. 
3. 
4. 
5. 
6. 
7. 

Comprehensive women’s
health history
Breast and pelvic exam
Two-handed surgical knot
Intrapartum cervical exam
Ruptured membranes
evaluation
Fetal heart rate monitor
interpretation
Pap smear and cervical
cultures

8.  Names and uses of basic
surgical instruments
9.  Wet mount interpretation
of vaginal discharge
10.  Suture types and
properties
11.  2nd degree vaginal
laceration repair
12.  Spontaneous vaginal
delivery
13.  Endometrial biopsy
14.  IUD Insertion


Curriculum Sources
•  Search for existing teaching and learning tools
–  Open-access, peer-reviewed (e.g. PubMed,
MedEdPortal)
–  Professional societies (e.g. APGO, CREOG, ASCCP,
AIUM, CDC)

–  Commercial learning tools (e.g. GE Healthcare)


Curriculum Delivery
1.  Live didactics (12 hours)
–  Lecture, case-based discussion, webinar

2.  Live skills labs (50 hours)
–  Self-directed online videos

3.  Self-directed learning (4 hours)
–  Computer-based training

Curriculum Schedule
Day 1

Day 2

Day 3

Orientation

Day 4

Day 5

Didactics (1.5 hrs)

Baseline
Skills
Assessment

Skills Labs (3.0 hrs)

Debrief



Curriculum Schedule
Day 6

Day 7

Day 8

Didactics (1.5 hrs)


Day 9

Day 10
Debrief

Final
Skills
Assessment



Study Assessments
•  Medical Knowledge
–  NBME ObGyn Subject Exam
–  Surgical instrument identification
–  Suture identification
–  Surgical needle / blade identification


Study Assessments
•  OSCE (Standardized Patient)
–  Comprehensive women’s health history
–  Breast and pelvic exam


Study Assessments
•  OSAT
–  Two-handed square knot
–  IUD insertion
–  Endometrial biopsy
–  Intrapartum cervical assessment
–  Spontaneous vaginal delivery
–  2nd degree vaginal laceration repair

Assessment Design
•  Analysis of published guidelines, texts
•  Development of anchored checklist
–  Complete
–  Incomplete
–  Not performed

•  Reviewed by 1-2 faculty for content validity


Performance Checklist

Assessment Design
Name:
Site:

CMC FSU GHS MCG MUSC USC UT-Mem UT-Knox

Cannot Judge

Not Done


Complete

Grading Key:
Complete (2 points) = Examinee performed the task meeting all criteria in the
description.
Incomplete (1 point) = Examinee performed the task, but failed to meet all criteria in the
Competency Assessment
description.
Not Done (0 points) = Examinee failed to perform the task. Vaginal Delivery
Station 3: Normal
Cannot Judge (0 points) = Unable to determine if the examinee performed the task.

Incomplete

Date:


General Approach / Interpersonal Communication Skills

Name:

2

MUSC USC UT-Mem UT-Knox

Examinee used either hand sanitizer or soap/water and proper technique to clean
his/her hands upon entering the room.

Introduction / Communication

Incomplete

Complete

Grading Key:
Upon entering the room, examinee greeted the patient, stated his/her name,
Complete (2 points) = Examinee performed the task meeting all criteria in the participate in her care.
ascertained/confirmed the patient’s name and voiced intent to
description.
Incomplete (1 point) = Examinee performed the task, but failed to meet all criteria in the
description.
Not Done (0 points) = Examinee failed to perform the task.
Labor Assessment / Preparation
Cannot Judge (0 points) = Unable to determine if the examinee performed the task.

3
Examination
Examinee verbalized intent to perform a pelvic exam, performed the exam and then

Cannot Judge

Date:

Hand Cleansing
CMC FSU GHS MCG

Not Done

1

Site:

verbalized the need to prepare for delivery.
General Approach / Interpersonal Communication Skills

Delivery table
1 4 Hand Cleansing
The examinee positioned the delivery table within arms reach.
Examinee used either hand sanitizer or soap/water and proper technique to clean
his/her hands upon entering the room.

2

Introduction / Communication
Universal Precautions
Upon entering the room,
the patient, stated his/her name,
APGO Medical Educationexaminee greetedFund and the to participate in her care. System Office of Philanthropy and Partnership
Endowment and voiced intent Greenville Hospital
ascertained/confirmed the patient’s name

Study Interventions
•  Baseline Self-Assessment of Competency
•  GO FOR IT Group:
–  Relocated to Greenville, SC
–  April 15th – 26th, 2013
–  Participated in curricular activities

•  Control Group:
–  Usual activities

End-of-study Assessments
•  NBME ObGyn Subject Exam
–  June 15th – June 29th, 2013
–  Prometric testing center
–  Scheduled at student’s convenience


•  OSCE / OSAT Assessments:
–  June 18th – July 2nd, 2013
–  Conducted at 5 of the collaborative centers
–  Standardized assessment toolbox
–  Video recording of all procedural stations


•  Assessment Toolbox:
–  Learning Outcomes
–  Case Scenario (if applicable)
–  Materials / Supplies / Personnel
–  Student Instructions
–  Assessment Checklist
–  Photos
–  Scoring Instructions (if applicable)

Data Management
•  Scored immediately at time of testing by
Proctor:
–  Health History OSCE
–  Breast and Pelvic Exam OSCE
–  Vaginal Delivery OSAT
–  2nd Degree Vaginal Laceration Repair OSAT

Data Management
•  Scored post-hoc at Data Coordination
Center (DCC) via video review:
–  IUD Insertion OSAT
–  Endometrial Biopsy OSAT


Data Management
•  Scored post-hoc at DCC:
–  Square Knot
–  Intrapartum Cervical Assessment
–  Instruments, Sutures, Needles, Blades
Identification


Study Outcomes
•  Primary:
–  Composite score of all OSCE / OSAT end-ofstudy assessments

•  Secondary:
–  Individual OSCE / OSAT assessment scores
–  NBME percentile score

Sample Size and Power
•  Estimate of Primary Outcome:
–  GO FOR IT Group:

80%

–  Control Group:

64%

–  Standard Deviation: 15%

•  Alpha: .05

Power: 80%

•  Two-tailed t-test
Sample Size = 15 subjects per group

Data Analysis
•  All data entered into Research Electronic
Data Capture (REDCap) at DCC
•  Exported to SPSS for analysis
–  Descriptive statistics
–  Student t-test for continuous data
–  Chi-square for categorical data

Enrollment Results
42

Matched into
OBGYN

9

2

21

10

Available to
Participate in either
Study Group

Willing to
Participate with
School Permission

Able to participate
in Control Group
only

Declined
Participation

11

21

GO FOR IT
Group

Control
Group


Demographics
GO FOR IT
(N=11)

Control
(N=21)

P value

27

26

.3

Graduation in 2013

91%

100%

.4

USMLE Results
Step 1
Step 2 CK
Step 2 CS (pass)

224
241
100%

221
238
95%

.6
.5
.6

Characteristic
Age (yrs)


M3/M4 Experience
11.7 wks
9.4 wks
6.5 wks

5.4 wks


M3/M4 Experience

72.7%

77.7%

81.8%
50.0%


Self-rated Competence
GO FOR IT
(N=11)

Control
(N=21)

P value

Two-handed knot tying

2.9 ± 0.7

3.6 ± 0.7

.01

Normal vaginal delivery

1.9 ± 0.3

2.5 ± 0.5

.001

Clinical Skill / Procedure

•  1 = I am unable to perform the entire procedure under supervision
•  2 = I am able to perform the procedure under supervision
•  3 = I usually do not require supervision but may need help
occasionally
•  4 = I am competent to perform the procedure unsupervised (I can
deal with complications).

Primary Outcome
Composite Score on OSCE / OSAT
GO FOR IT

Control

70.8%

40.6%

SD =13.2

vs.

SD =19.5

p=.0003

Secondary Outcomes
80.0%

76.8%
59.0%

59.7%


Secondary Outcomes

65.5%

56.4%
26.0%

26.0%


Secondary Outcomes
90.2%
62.1%
36.6%

49.6%


Secondary Outcomes

62.9%

61.0%
41.3%

55.8%


Secondary Outcomes
83.9%
61.3%
25.0%

32.9%


Secondary Outcomes

75.8%

69.3%

58.9%
28.6%

26.7%
6.9%


Secondary Outcomes
Square Knot
GO FOR IT

Control

100%

85.7%

(11/11)

vs.

(18/21)

p=.5

Secondary Outcomes
NBME ObGyn Subject Exam
Overall-year percentile
GO FOR IT

Control

57.8

49.6

SD = 29.0

vs.

SD =28.9

p=.5

Conclusion
Participation in an intensive twoweek post residency-match M4
elective results in significantly
greater clinical, procedural, and
knowledge competency as
compared to the usual activities
students pursue at the conclusion of
the M4 year.


Discussion
•  Greatest impact on procedural skills
•  Lesser impact on medical knowledge
•  Effect was sustained over 8-10 week period
between training and final testing
•  Self-rated competency did not correlate with
outcomes


Weaknesses
•  Quasi-experimental design
•  Un-weighted procedural checklists
•  Non-blinded procedural rating
•  Exposure bias in GO FOR IT group
•  Unknown transference to actual clinical
performance and outcomes


Strengths
•  Multicenter
•  Large sample size
•  Heterogeneous study population
•  Reproducible curriculum based on national
recommendations and non-proprietary tools
•  Multiple forms of competency assessment


Recommendations
•  OBGYN educators should implement
intensive residency preparation opportunities
near the end of the M4 year to assure
achievement of desired competency prior to
starting residency


Course Length/Content


Course Timing


Financial Responsibility


Participant Comments
“Thank you Thank you Thank you. You have
saved my butt. I didn't realize how much I had
forgotten and how much I didn't know. You have
made me feel much more confident and
competent going into July.”
“The amount of confidence gained from this
course alone has made it worthwhile. I don't feel
as much as an imposter anymore :)”

GO FOR IT Trial Oral Abstract Presentation

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